CompletedPhase 1

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult Volunteers

United States40 participantsStarted 2013-05

Plain-language summary

The purpose of this study is to evaluate the safety and tolerability of healthy male and female subjects with intravenous (IV) infusions of AVI 7288 compared to matched placebo in and to evaluate the pharmacokinetics (PK).

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓.Man or woman 18 to 50 years of age, inclusive, at the time of screening. 2.Body mass index 18 kg/m2 to 35 kg/m2, inclusive, at the time of screening and Check-in (Day -1).3.Good general health (no chronic health conditions) as determined by the Investigator.4.Female subjects must be of non-childbearing potential or must, in conjunction with their sexual partner(s), use 2 forms of medically acceptable barrier contraception (e.g., a diaphragm with spermicidal jelly in conjunction with a male condom) during the screening period and for the entire duration of the study including the 28-day post last dose follow-up.5.Male subjects must either be sterile or agree to use, for the entire duration of the study and for 90 days post last dose follow-up, a male condom and the female sexual partner must also use a medically acceptable form of birth control (e.g. oral contraceptives). 6. Male subjects must agree not to donate sperm for at least 90 days after the last infusion of study medication. 7.Able to understand the requirements of the study, to provide written informed consent (as evidenced by signature on an informed consent document that is approved by an Institutional Review Board (IRB), and agree to abide by the study restrictions.

Exclusion criteria

✕.Pregnancy or breastfeeding. 2. A positive urine or blood screen for drugs of abuse, including alcohol. 3.Use of any tobacco- or nicotine-containing products(including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1). 4.Donated blood within 90 days or plasma within 30 days of first dose on Day 1. 5.A positive cotinine test indicating recent nicotine use.6.Active substance abuse or any medical or psychiatric condition that could jeopardize the subject's safety or the subject's ability to comply with the protocol. 7.Use of any medications apart from vitamins, acetaminophen or hormonal contraception within 14 days of first dose on Day 1. Subjects with mild seasonal allergies may use antihistamines at the discretion of the Investigator after discussion with the Sponsor Medical Monitor.8.Participation in any interventional clinical trial within 45 days of first dose on Day 1 (i.e., received any other investigational drug).9. Recipient of an organ transplant (solid or hematopoietic). 10.Prolonged QTcF interval \>(440 ms) for males or \> 460 ms for females using the average of the triplicate ECGs collected during screening, on Day -1, or just prior to dosing on Day 1. 11.Other clinically significant electrocardiogram (ECG) abnormality, as determined by the Investigator. 12.Any clinically significant abnormal hematology, chemistry, coagulation, or urinalysis value, as determined by the Investigator. 13.Glomerular filtration rate (GFR) of \< 90 mL/min, based on the Modification of Diet in Renal Disease equation.14.Urine-albumin-to-creatinine ratio (UACR) \> 30 mg/g. 15.Positive test for human immunodeficiency virus (HIV-1 serology) or known HIV infection. 16.Positive result for hepatitis B surface antigen (HBsAg) or for hepatitis C virus (HCV) antibody.17.Use of alcohol-containing foods or beverages within 72 hours prior to Check-in on Day -1.18.Use of caffeine-containing foods or beverages within 24 hours prior to Check-in on Day 1. 19.Febrile illness or significant infection within 48 hours before administration of the first dose of study drug on Day 1.

What they're measuring

The outcome measure is safety, as assessed through adverse event evaluation and serial clinical assessments.

Timeframe: daily during dosing period with follow up on Day 21 and Day 42

Trial details

NCT IDNCT01566877

SponsorSarepta Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-01

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